Acute submassive (intermediate-high risk) pulmonary embolism Circulatory System
Conditions
Interventions
In local anesthesia, after femoral vein puncture and 8F sheath insertion, the 6F pigtail catheter (0.035’ standard wire-supported) is introduced into the pulmonary trunk using a typical technique. The
Sponsors
St. John Paul II Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinical signs, symptoms, and presentation consistent with acute pulmonary embolism (PE) 2. PE symptom duration of 14 days or less 3. CT angiography (CTA) evidence of PE 4. RV/LV ratio of 0.9 or greater measured via CT, as determined by the investigational site 5. Heart rate less than 130 beats per minute prior to procedure 6. Subject deemed medically eligible for interventional procedure(s), per institutional guidelines and/or clinical judgment 7. Age between 18 and 74 years
Exclusion criteria
Exclusion criteria: 1. Thrombolytic use within 14 days of baseline CTA 2. Known bleeding diathesis or coagulation disorder 3. Any contraindication to systemic therapeutic doses of heparin or other anticoagulants 4. Hemodynamic collapse at presentation defined as any of the below: 4.1. Need for cardiopulmonary resuscitation 4.2. Systolic blood pressure 90 mm Hg 5. Decompensated heart failure 6. Presence of Extra-Corporeal Membrane Oxygenation 7. Major trauma ISS > 15 within 14 days 8. Cardiovascular or pulmonary surgery within last 7 days 9. FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90% 10. Laboratory findings: 10.1. Hematocrit 1.8 mg/dL 10.4. INR > 2 11. Left bundle branch block 12. Pulmonary hypertension with peak PAP > 70 mmHg measured either by echocardiography or right heart catheterization 13. Imaging evidence or other evidence that suggests the subject is not appropriate for mechanical thrombectomy intervention 14. Presence of intracardiac lead in right ventricle or atrium 15. Pacemaker or Implantable Cardioverter Defibrillator 16. Presence of intracardiac thrombus 17. Known anaphylactic reaction to radiographic contrast agents that cannot be pre-treated 18. Known right-to-left shunt, for example from large patent foramen ovale or arterial septal defect 19. Known left ventricular ejection fraction = 30% 20. History of severe chronic pulmonary arterial hypertension 21. History of underlying lung disease with oxygen dependence 22. History of chest irradiation 23. History of Heparin Induced Thrombocytopenia (HIT) 24. Female who is pregnant or nursing 25. Current participation in another investigational drug or device treatment study 26. Life expectancy of < 90 days as determined by the investigator 27. Subjects who are intubated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined (hierarchical) clinical endpoint of death by 30-days or NYHA>2 at 7-days post-procedure or oxygen therapy need at 72-hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured using patient records: 1. Failure to reach at least 30% reduction in RV/LV ratio by CTA at 48 hours 2. Death by 30 days 3. NYHA class greater than 2 at 7 days post-procedure 4. Oxygen therapy needed at 72 hours 5. In-hospital death 6. Major bleeding during procedure 7. Pulmonary artery injury during procedure 8. Cardiac tamponade during procedure 9. Clinical deterioration during the procedure 10. Cardiac arrest during the procedure 11. Duration of hospitalization 12. RV/LV ratio at 48 hours 13. Percentage RV/LV ratio reduction 14. Pulmonary artery systolic pressure reduction at end of procedure 15. Pulmonary artery mean pressure reduction at end of procedure 16. NT-proBNP level at 48 hours (pg/ml) 17. Hemoglobin level at 48 hours (g/dl) 18. Need for red blood cell transfusion 19. Total number of days of hospitalization 20. CTA evidence of pulmonary offload (Miller score) at 48h vs baseline | — |
Countries
Poland
Contacts
Public ContactPiotr Musialek
Outcome results
None listed